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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036532
Receipt No. R000041613
Scientific Title Study aimed at establishment of clinical diagnostic criteria and guideline by using a multicenter registry of patients with IgG4-related disease
Date of disclosure of the study information 2019/07/27
Last modified on 2019/11/29

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Basic information
Public title Study aimed at establishment of clinical diagnostic criteria and guideline by using a multicenter registry of patients with IgG4-related disease
Acronym Registry-based study in IgG4 -related disease
Scientific Title Study aimed at establishment of clinical diagnostic criteria and guideline by using a multicenter registry of patients with IgG4-related disease
Scientific Title:Acronym Registry-based study in IgG4 -related disease
Region
Japan

Condition
Condition IgG4-related disease
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Cardiology Pneumology Endocrinology and Metabolism
Hematology and clinical oncology Nephrology Neurology
Clinical immunology Ophthalmology Oto-rhino-laryngology
Urology Radiology Neurosurgery
Cardiovascular surgery
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To clarify natural history and prognostic factor of IgG4-related disease by consistent and long-term investigation based on a patients registry.
Basic objectives2 Others
Basic objectives -Others Elucidating prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of mortality, relapse, and cancer development in IgG4-related disease.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients diagnosed as definite, probable and possible IgG4-related disease according to comprehensive diagnostic criteria.
2. Patients who agree about informed consent concerning this study.
Key exclusion criteria 1. Patients in whom similar disease (cancer, Sjogren's syndrome, primary sclerosing cholangitis, Castleman's disease, secondary retroperitoneal fibrosis, Wegener's granulomatosis, sarcoidosis, Churg-Strauss syndrome) cannot be ruled out.
2. Patients who be regarded as inadequate subjects by researchers.
Target sample size 9999

Research contact person
Name of lead principal investigator
1st name Kazuichi
Middle name
Last name Okazaki
Organization Kansai Medical University
Division name The Third Department of Inetrnal Medicine
Zip code 573-1010
Address 2-5-1, Shinmachi, Hirakata, Osaka
TEL 072-804-0101
Email igg4@hirakata.kmu.ac.jp

Public contact
Name of contact person
1st name Tsukasa
Middle name
Last name Ikeura
Organization Kansai Medical University
Division name The Third Department of Inetrnal Medicine
Zip code 573-1010
Address 2-5-1, Shinmachi, Hirakata, Osaka
TEL 072-804-0101
Homepage URL
Email igg4@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare (Japan)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto University Graduate School and Facility of medicine, Kyoto Uniiversity Hospital , Ethics Committe
Address 54 Kawaharacho, Shogoin, Sakyo-ku Kyoto
Tel 075-753-4680
Email ethcom@kuhp.kyoto-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 07 Month 27 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2019 Year 03 Month 07 Day
Date of IRB
2019 Year 10 Month 28 Day
Anticipated trial start date
2019 Year 11 Month 29 Day
Last follow-up date
2034 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The data collected in this study are shared with Rare Disease Data Registry of Japan supported by Japan Agency for Medical Research and Development (AMED).

Management information
Registered date
2019 Year 04 Month 17 Day
Last modified on
2019 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041613

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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